cGMP Assurance Lead

6 days ago


Berkeley Heights, New Jersey, United States Breckenridge Pharmaceutical Inc Full time
cGMP Assurance Lead
Breckenridge Pharmaceutical Inc is seeking an experienced cGMP Assurance Lead to join our Quality Assurance team. In this role, you will be responsible for ensuring that all aspects of our business comply with cGMP regulations and industry standards.

About the Role
The ideal candidate will have a strong background in Quality Assurance and Compliance, with experience in managing SOP systems, conducting third-party audits, and resolving batch deviations. You will also have excellent communication and problem-solving skills, as well as the ability to work independently and collaboratively as part of a team.

Key Responsibilities
- Develop and implement SOPs to ensure compliance with cGMP regulations
- Conduct regular audits of contract manufacturers and vendors to ensure compliance with cGMP regulations
- Investigate and resolve batch deviations and OOS reports
- Collaborate with cross-functional teams to identify and implement process improvements

Requirements
- Bachelor's degree in a scientific discipline (e.g., biology, chemistry, pharmacy)
- Minimum 10 years of experience in Quality Assurance and Compliance
- Proven track record of implementing effective compliance programs

Estimated Salary: $160,000 - $220,000 per year depending on experience.
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